Patent expiration and increased use of traditional generic drugs are leading to a shift of focus in the pharmaceutical industry toward investment in specialty drugs and high growth areas such as biosimilars. Expensive biopharmaceuticals are largely used for life-saving disorders such as cancer and diabetes, the incidence of which is increasing with population aging in Europe. Moreover, patent expiry of key product classes and a growing emphasis on cost effectiveness are making governments switch to affordable alternatives. There is thus a tremendous opportunity for biosimilar manufacturers. However, the development of biosimilar drugs is riddled with complexities, from R&D to manufacturing to marketing, and is

Patent expiration and increased use of traditional generic drugs are leading to a shift of focus in the pharmaceutical industry toward investment in specialty drugs and high growth areas such as biosimilars. Expensive biopharmaceuticals are largely used for life-saving disorders such as cancer and diabetes, the incidence of which is increasing with population aging in Europe. Moreover, patent expiry of key product classes and a growing emphasis on cost effectiveness are making governments switch to affordable alternatives. There is thus a tremendous opportunity for biosimilar manufacturers. However, the development of biosimilar drugs is riddled with complexities, from R&D to manufacturing to marketing, and is one of the most expensive propositions in the pharmaceutical industry.

About 30 companies are actively developing biosimilar medicines and are researching on the biosimilar versions of 16 distinct molecules that will lead to greater competition by 2020, with 8 major biologic medicines expected to lose exclusivity by 2020.

The next five years are going to be an interesting period in the biosimilars market as a number of biologic drugs are going to lose their exclusivity. On the one hand, this will significantly reduce costs for patients and health systems, on the other, it will pose challenges for regulators to confirm the similarity of the biosimilar to the original biologic in terms of efficacy and safety. The experience of European healthcare companies has been encouraging in the 10 years since the endorsement of the first biosimilar in the EU.

Pricing and physician awareness and support from the regulatory agencies are expected to be key factors driving success in the biosimilars market. Europe is expected to remain the largest contributor to biosimilars revenue worldwide for the next 5–7 years.

The study analyzes the supply market dynamics and forecasts future revenues for key biosimilars in the European region. It also identifies the six key issues to determine the strategic imperatives for success and growth in this market. Moreover, it includes an in-depth analysis of the biosimilar value chain and the payer and regulatory environment. By assessing the impact of trends, disruptive technologies, and new business models, the study arrives at key visioning scenarios for the biosimilars market in Europe. These will help market participants make strategic decisions, stay ahead of their competitors, and gain a significant share in the market. The study also sheds light on strategic partnerships among companies in the European biosimilars market.

Highlights of the report include:• Growth Opportunities and Challenges• Supply Market Dynamics• Payer and Regulatory Environment Analysis• Strategic Imperatives for Success and Growth–The Six Tactical Issues• Visioning Scenarios for the Biosimilars Market• Business Model Essentials• A Macro Overview of the Biosimilars Market Read Less